Exhibit 10.34


 



SECOND AMENDMENT TO RESEARCH AND LICENCE AGREEMENT


(this “Amendment”)







Effective Date: November 28, 2016







By and between







YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED


a company duly registered under the laws of Israel of P O Box 95, Rehovot 76100, Israel


(hereinafter, “Yeda”)







and







CELL SOURCE LIMITED


a company duly registered under the laws of Israel of 5 Kineret Street, Bnei Brak  5126237


(hereinafter, “Cell Source”)








	WHEREAS	
Yeda and Cell Source are parties to a research and licence agreement dated October 3rd, 2011, as amended by a first amendment thereto dated April 8, 2014 (together, "the R&L Agreement”); and













	WHEREAS	
Cell Source has notified Yeda in writing that it does not wish to exercise its option rights under the Evaluation and Exclusive License Agreement between the parties dated October 3rd, 2011 (as amended from time to time), and the parties wish to amend the R&L Agreement accordingly; and













	WHEREAS	
the parties also wish to update Appendix A (Patent Cards) of the R&L Agreement, to amend the development milestones and to make certain additional amendments to the R&L Agreement, all subject to the terms and conditions set out in this Amendment below.












NOW THEREFORE IT IS AGREED BY THE PARTIES HERETO AS FOLLOWS:








	1.	
Terms and phrases used in this Amendment which are defined in the R&L Agreement shall have in this Amendment the same meaning as that attributed to them in the R&L Agreement, unless otherwise expressly defined in this Amendment.













	2.	
This Amendment and the R&L Agreement shall be read as one and shall represent the complete current understanding between the parties with respect to the subject matter hereof. Subject to the modifications contained herein, the provisions of the R&L Agreement shall remain unaltered and in full force and effect.













	3.	
The above preamble forms an integral part of this Amendment.







 












 



	
4.

	
The R&L Agreement shall be modified, as of the Effective Date, as follows:













	4.1	
In the first paragraph of the preamble thereto, the numbers “2000-017, 2005-082, 2008-108, 2010-071, 2010-073, 2011-077” shall be deleted and replaced by the following: “2000-017, 2008-108, 2010-073, 2011-077, 2011-095, 2015-049, 2015-062, 2016-027” and Appendix A to the R&L Agreement shall be replaced in its entirety by Annex A of this Amendment;













	4.2	
The final paragraph of the preamble thereto (including Appendix 1 thereto which is referenced in said paragraph) shall be deleted in its entirety;













	4.3	
Clause 3 thereto shall be amended such that the words: “provided that, in the event the a R&L Agreement shall be executed between the parties in accordance of the E&O Agreement (as amended), then the annual Research Budget in respect of the Research Period shall, beginning on the date such R&L Agreement shall be signed, be an amount of US$ 900,000 (nine hundred thousand US Dollars) per year” shall be deleted;













	4.4	
The final paragraph of clause 3 thereto shall be deleted in its entirety and replaced by the following:












“In addition to the sums detailed in this clause 3 above, within 7 (seven) days of the achievement of the Company of the receipt of an aggregate total equity capital investment in the Company of more than $10,000,000 (ten million US dollars), the Company shall pay Yeda a non-refundable payment in the sum of US $200,000 (two hundred thousand US Dollars) (the “Additional Research Payment”). The Additional Research Payment shall be allocated by Yeda to support research activities of the Scientist under this Agreement according to an additional Research plan to be submitted to the Company by Yeda.








	4.5	
In clause 4 thereto, the words “3 (three) month” shall be deleted wherever they appear and replaced by the words “6 (six) month”;













	4.6	
Clause 13.2.1 shall be deleted in its entirety and replaced by the following:













		“13.2.1	
If the Company fails to achieve any one of the milestones set forth in sub-clauses (a) to (e) below by the dates specified therefor, Yeda shall be entitled, at its option: (i) to modify the Licence hereunder so that it is non-exclusive only, by written notice to the Company (any such amendment of this Agreement by Yeda as aforesaid, being effective immediately, the Company’s consent thereto (written or otherwise) not being required, notwithstanding the provisions of clause 17.2 below); or (ii) to terminate this Agreement (including the Licence hereunder) by giving the Company 30 (thirty) days’ written notice:












(a) by January 1, 2018, to have successfully filed a pre-IND application in respect of a Product with the FDA or other equivalent regulatory agency in another country;







(b) by January 1, 2021, to have commenced Phase II clinical trials in a respect of a Product;


 



2


















(c) by July 1, 2023, to have either commenced Phase III clinical trials or to have received FDA or EMA marketing approval in a respect of a Product (“Marketing Approval”);







(d) within 12 (twelve) months from the date of Marketing Approval, to have made a First Commercial Sale of a Product; or







(e) in case commercial sale of any Product having commenced, there shall be a period of 12 (twelve) months or more during which no sales of any Product shall take place by the Company or its Sublicensees (except as a result of force majeure or other factors beyond the control of the Company).";








	4.7	
In clause 13 thereto, the words “which has not been cured by the party in breach within 21 (twenty-one) days (or, in the case of failure by the Company to pay any amount due from the Company to Yeda pursuant to or in connection with this Agreement on or before the due date of payment, 10 (ten) days)” shall deleted and replaced by the words: “which has not been cured by the party in breach within 30 (thirty) days”;












and








	4.8	
Yeda’s bank details in clause 17.7 thereto shall deleted and replaced by the following: “Bank Leumi le–Israel B.M., Rehovot business branch, 2 Ilan Ramon Street, Ness Ziona, branch #978, account no. 6370094; swift: LUMIILITTLV, Routing Number: IL010978, IBAN no. IL7401 09780 0000 0637 0094”.













	
5.

	
For the avoidance of doubt, this Amendment constitutes the entire agreement between the parties hereto in respect of the subject matter hereof, and supersede all prior agreements or understandings between the parties relating to the subject matter hereof (including any previous correspondence in this regard, between the parties, or on their behalf) and may be amended only by a written document signed by both parties hereto.












[signature page follows]




  



3


















IN WITNESS WHEREOF the parties hereto have set their signatures as of the Effective Date.







	
For    YEDA RESEARCH AND DEVELOPMENT COMPANY LIMITED

	 	
For    CELL SOURCE LIMITED


	 	 	 	 	 
	
Signature:

	
/s/ Mudl Sheves


/s/ Gil Granot-Mayor

	 	
Signature:

	
/s/ Itamar Shimrat


	 	 	 	 	 
	
Name

	
Prof. Mudl Sheves


Gil-Granot-Mayor

	 	
Name:

	
Itamar Shimrat


	
Title

	
Chairman

 CEO

	 	
Title:

	
Chief Executive Officer
















4


















Annex A – Updated Patent Cards


 


PATENT CARD


 


2000-017


 


Title: VETO CELLS EFFECTIVE IN PREVENTING GRAFT REJECTION AND DEVOID OF GRAFT VERSUS HOST POTENTIAL


 


Inventors: REISNER Yair, MARTELLI Massimo


 


	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
05/01/2000 - 09/477,737

	
-

	
6,544,506 - 08/04/2003

	
Granted


	
PCT

	
28/12/2000 - PCT/IL00/00872

	
12/07/2001 - WO 01/49243

	
-

	
Published


	
European Patent Office

	
28/12/2000 - 00983473.0

	
02/10/2002 - 1 244 803

	
1 244 803 - 22/02/2006

	
Validated


	
   France

	
28/12/2000 - 00983473.0

	
-

	
1 244 803 - 22/02/2006

	
Granted


	
   Germany

	
28/12/2000 - 00983473.0

	
-

	
60026166.2 - 22/02/2006

	
Granted


	
   Italy

	
28/12/2000 - 00983473.0

	
-

	
1 244 803 - 22/02/2006

	
Granted


	
   Switzerland

	
28/12/2000 - 00983473.0

	
-

	
1 244 803 - 22/02/2006

	
Granted


	
   United Kingdom

	
28/12/2000 - 00983473.0

	
-

	
1 244 803 - 22/02/2006

	
Granted


	
Israel

	
28/12/2000 - 150440

	
-

	
150440 - 31/03/2011

	
Granted


	
U.S.A

	
28/12/2000 - 10/169,028

	
-

	
7,270,810 - 18/09/2007

	
Granted










 


PATENT CARD


 


2008-108


 


Title: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT


 


Inventors: REISNER Yair, OPHIR Eran, EIDELSTEIN Yaki, BACHAR-LUSTIG Esther







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
30/10/2008 - 61/193,137

	
-

	
-

	
Expired


	
U.S.A

	
12/06/2009 - 61/213,482

	
-

	
-

	
Expired


	
PCT

	
29/10/2009 - PCT/IL2009/001014

	
06/05/2010 - WO 2010/049935

	
-

	
Published


	
China

	
29/10/2009 - 200980153053.4

	
07/12/2011 - 102271702

	
ZL200980153053.4 - 25/11/2015

	
Granted


	
European Patent Office

	
29/10/2009 - 09764302.7

	
21/09/2011 - 2 365 823

	
-

	
Pending


	
India

	
29/10/2009 - 905/MUMNP/2011

	
-

	
-

	
Pending


	
Israel

	
29/10/2009 - 212587

	
-

	
212587 - 01/04/2016

	
Granted


	
Russian Federation

	
29/10/2009 - 2011121630

	
-

	
2506311 - 10/02/2014

	
Granted


	
U.S.A

	
29/10/2009 - 13/126,472

	
01/09/2011 - 2011-0212071

	
-

	
Pending





 



5















 


PATENT CARD


 


2010-073


 


Title: USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS FOR ANTI-LEUKEMIA/LYMPHOMA TREATMENT


 


Inventors: REISNER Yair, LASK Assaf, OPHIR Eran, OR-GEVA Noga, COHEN Adva







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
08/09/2010 - 61/380,716

	
-

	
-

	
Expired


	
PCT

	
08/09/2011 - PCT/IL2011/000727

	
15/03/2012 - WO 2012/032526

	
-

	
Published


	
Brazil

	
08/09/2011 - BR 11 2013 005756 4

	
31/12/2013 - BR 11 2013 005756 4

	
-

	
Published


	
Canada

	
08/09/2011 - 2,810,632

	
-

	
-

	
Pending


	
China

	
08/09/2011 - 201610307275.9

	
31/08/2016 - CN 105907713 A

	
-

	
Published


	
China

	
08/09/2011 - 201180053858.9

	
04/09/2013 - CN 103282047 A

	
ZL201180053858.9 - 24/08/2016

	
Granted


	
European Patent Office

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Validated


	
   Austria

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Belgium

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Czech Republic

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   France

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Germany

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Greece

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Hungary

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Ireland

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Italy

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Poland

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Portugal

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Spain

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Sweden

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Switzerland

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   The Netherlands

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   Turkey

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted


	
   United Kingdom

	
08/09/2011 - 11773325.3

	
17/07/2013 - 2 613 801

	
2 613 801 - 08/06/2016

	
Granted





 



6















 


 


	
Hong Kong

	
08/09/2011 - 14100513.2

	
-

	
-

	
Allowed


	
Israel

	
08/09/2011 - 225102

	
-

	
-

	
Pending


	
Japan

	
08/09/2011 - 2013-527738

	
30/09/2013 - P2013-537187A

	
5,977,238 - 29/07/2016

	
Granted


	
Korea

	
08/09/2011 - 2013-7008892

	
-

	
-

	
Pending


	
Mexico

	
08/09/2011 - MX/a/2013/002668

	
-

	
-

	
Pending


	
Singapore

	
08/09/2011 - 201301743-9

	
-

	
188473 - 26/01/2016

	
Granted


	
U.S.A

	
08/09/2011- 15/242,666

	
-

	
-

	
Pending


	
U.S.A

	
08/09/2011 - 13/821,255

	
04/07/2013 - 2013-0171108-A1

	
9,421,228 - 23/08/2016

	
Granted










PATENT CARD


 


2011-077


 


Title: ANTI THIRD PARTY CENTRAL MEMORY T CELLS, METHODS OF PRODUCING SAME AND USE OF SAME IN TRANSPLANTATION AND DISEASE TREATMENT


 


Inventors: REISNER Yair, EIDELSTEIN Yaki, OPHIR Eran, LASK Assaf, AFIK Ran, BACHAR-LUSTIG Esther, OR-GEVA Noga







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
08/09/2011 - 61/532,172

	
-

	
-

	
Expired


	
PCT

	
06/09/2012 - PCT/IL2012/050354

	
14/03/2013 - WO 2013/035099

	
-

	
Published


	
Australia

	
06/09/2012 - 20120305931

	
-

	
-

	
Pending


	
Brazil

	
06/09/2012 - BR 11 2014 005355 3

	
21/10/2014 -

	
-

	
Published


	
Canada

	
06/09/2012 - 2,848,121

	
-

	
-

	
Pending


	
China

	
06/09/2012 - 201280054739.X

	
16/07/2014 - CN 103930130 A

	
201280054739.X - 06/06/2016

	
Granted


	
European Patent Office

	
06/09/2012 - 12769743.1

	
16/07/2014 - 2753351

	
-

	
Pending


	
Hong Kong

	
06/09/2012 - HK 15100534.6

	
31/07/2015 - 1200099A

	
-

	
Published


	
India

	
06/09/2012 - 577/MUMNP/2014

	
-

	
-

	
Pending


	
Israel

	
06/09/2012 - 231397

	
-

	
-

	
Pending


	
Japan

	
06/09/2012 - 2014-529143

	
06/10/2014 - P2014-526244A

	
-

	
Published


	
Korea

	
06/09/2012 - 10-2014-7009267

	
23/07/2014 - 10-2014-0092298

	
-

	
Published


	
Mexico

	
06/09/2012 - MX/a/2014/002771

	
-

	
-

	
Pending


	
New Zealand

	
06/09/2012 - 622749

	
-

	
622749 - 02/02/2016

	
Granted


	
Russian Federation

	
06/09/2012 - 2014110897

	
-

	
-

	
Pending


	
Singapore

	
06/09/2012 - 11201400513P

	
-

	
-

	
Pending


	
South Africa

	
06/09/2012 - 2014/01993

	
19/09/2014 -

	
-

	
Allowed


	
U.S.A

	
06/09/2012 - 14/343,053

	
31/07/2014 - 2014-0212398

	
-

	
Pending







  



7


















PATENT CARD


 


2011-095


 


Title: A COMBINATION THERAPY FOR A STABLE AND LONG TERM ENGRAFTMENT USING SPECIFIC PROTOCOLS FOR T/B CELL DEPLETION


 


Inventors: REISNER Yair, BACHAR-LUSTIG Esther







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
22/12/2011 - 61/578,917

	
-

	
-

	
Expired


	
PCT

	
20/12/2012 - PCT/IL2012/050542

	
27/06/2013 - WO 2013/093920

	
-

	
Published


	
PCT

	
20/12/2012 - PCT/IL2012/050541

	
27/06/2013 - WO 2013/093919

	
-

	
Published


	
Australia

	
20/12/2012 - 2012355990

	
-

	
-

	
Pending


	
Australia

	
20/12/2012 - 2012355989

	
-

	
-

	
Pending


	
Brazil

	
20/12/2012 - BR 11 2014 015960 2

	
21/10/2014 -

	
-

	
Pending


	
Brazil

	
20/12/2012 - BR 11 2014 015959 9

	
-

	
-

	
Pending


	
Canada

	
20/12/2012 - 2,859,953

	
27/06/2013 -

	
-

	
Pending


	
Canada

	
20/12/2012 - 2,859,952

	
27/06/2013 -

	
-

	
Pending


	
China

	
20/12/2012 - 201280068202.9

	
25/03/2015 - CN 104470542 A

	
-

	
Pending


	
China

	
20/12/2012 - 201280068917.4

	
08/10/2014 - CN 104093314 A

	
-

	
Pending


	
European Patent Office

	
20/12/2012 - 12859036.1

	
29/10/2014 - 2793914

	
-

	
Pending


	
European Patent Office

	
20/12/2012 - 12861023.5

	
05/11/2014 - 2797421

	
-

	
Pending


	
Hong Kong

	
20/12/2012 - 15103467.1

	
09/10/2015 - 1202810A

	
-

	
Published


	
Hong Kong

	
20/12/2012 - 15103468.0

	
09/10/2015 - 1202775A

	
-

	
Published


	
India

	
20/12/2012 - 1468/MUMNP/2014

	
27/06/2013 -

	
-

	
Pending


	
India

	
20/12/2012 - 1467/MUMNP/2014

	
27/06/2013 -

	
-

	
Pending


	
Israel

	
20/12/2012 - 233303

	
27/06/2013 - WO 2013/093920

	
-

	
Pending


	
Israel

	
20/12/2012 - 233302

	
27/06/2013 - WO 2013/093919

	
-

	
Pending


	
Japan

	
20/12/2012 - 2014-548337

	
05/02/2015 - P2015-504047A

	
-

	
Pending


	
Japan

	
20/12/2012 - 2014-548336

	
22/01/2015 - 2015-502401

	
-

	
Pending


	
Korea

	
20/12/2012 - 10-2014-702449

	
04/09/2014 - 10-2014-0107564

	
2014/05071 - 25/11/2015

	
Granted


	
Korea

	
20/12/2012 - 10-2014-7020448

	
02/09/2014 - 10-2014-0105848

	
-

	
Published


	
Mexico

	
20/12/2012 - Mx/a/2014/007647

	
-

	
-

	
Pending


	
Mexico

	
20/12/2012 - Mx/a/2014/007648

	
27/06/2013 - WO 2013/093919

	
-

	
Pending


	
New Zealand

	
20/12/2012 - 627272

	
-

	
-

	
Pending


	
New Zealand

	
20/12/2012 - 627549

	
-

	
-

	
Pending





 



8















 


 


	
Russian Federation

	
20/12/2012 - 2014128479

	
-

	
-

	
Pending


	
Russian Federation

	
20/12/2012 - 2014129632

	
27/06/2013 - WO 2013/093919

	
-

	
Pending


	
Singapore

	
20/12/2012 - 11201403459X

	
-

	
-

	
Pending


	
Singapore

	
20/12/2012 - 11201403456U

	
-

	
11201403456U - 08/06/2016

	
Granted


	
South Africa

	
20/12/2012 - 2014/05071

	
-

	
2014/05071 - 25/11/2015

	
Granted


	
South Africa

	
20/12/2012 - 2014/05298

	
-

	
2014/05298 - 25/11/2015

	
Granted


	
U.S.A

	
20/12/2012 - 14/367,923

	
18/12/2014 - 2014-0369974

	
-

	
Published


	
U.S.A

	
20/12/2012 - 14/367,917

	
11/12/2014 - 2014-0363437

	
-

	
Published










PATENT CARD


 


2015-049


 


Title: USE OF ANTI THIRD PARTY CENTRAL MEMORY T CELLS


 


Inventors: OR-GEVA Noga, OPHIR Eran, REISNER Yair, EIDELSTEIN Yaki, GIDRON Rotem







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
16/07/2015 - 62/193,207

	
-

	
-

	
Expired


	
PCT

	
14/07/2016 - PCT/IL2016/050774

	
-

	
-

	
Pending










PATENT CARD


 


2015-062


 


Title: GENETICALLY MODIFIED ANTI-THIRD PARTY CENTRAL MEMORY T CELLS AND USE OF SAME IN IMMUNOTHERAPY


 


Inventors: OR-GEVA Noga, OPHIR Eran, REISNER Yair, EIDELSTEIN Yaki, GIDRON Rotem







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
16/07/2015 - 62/193,207

	
-

	
-

	
Expired


	
PCT

	
14/07/2016 -

	
-

	
-

	
Pending










PATENT CARD


 


2016-027


 


Title: VETO CELLS GENERATED FROM MEMORY T CELLS


 


Inventors: REISNER Yair, OR-GEVA Noga, GIDRON Rotem, BACHAR-LUSTIG Esther, LASK Assaf, KAGAN Sivan







	
Country

	
Application

	
Publication

	
Grant

	
Status


	 	 	 	 	 
	
U.S.A

	
27/06/2016 -

	
-

	
-

	
Pending














9